Source: FDA, National Drug Code (US) Revision Year: 2021
BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(NmethylN-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate with the molecular formula C9H22NO7P2Na•H2O and a molecular weight of 359.24. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water and practically insoluble in organic solvents.
Ibandronate sodium has the following structural formula:
BONIVA is available as a white, oblong, 150 mg film-coated tablet for once-monthly oral administration. One 150 mg film-coated tablet contains 168.75 mg ibandronate monosodium monohydrate, equivalent to 150 mg free acid. BONIVA also contains the following inactive ingredients: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal silicon dioxide, and purified water. The tablet film coating contains hypromellose, titanium dioxide, talc, polyethylene glycol 6000, and purified water.
| Dosage Forms and Strengths |
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BONIVA 150 mg tablets: white, oblong, engraved with “BNVA” on one side and “150” on the other side. |
| How Supplied |
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BONIVA 150 mg tablets: supplied as white, oblong, film-coated tablets, engraved with “BNVA” on one side and “150” on the other side. Packaged as a three-month supply in: A box with 1 blister pack containing 3 tablets (NDC 0004-0186-83). BONIVA is a registered trademark of Roche Therapeutics Inc. Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 |
| Drug | Countries | |
|---|---|---|
| BONIVA | United States, South Africa |
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